Phase 3
Completed N=48
Effect of Oral Pregabalin on Spinal Neurotransmitters in Patients Undergoing Knee Replacement
Source: ClinicalTrials.gov NCT00729690 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Dec 2012
Primary outcomePrimary: NRS Pain Score AUC (NRS*hr) - 1st 24 Hours — 70.4; 59.6; 73.4 Area (NRS*hr) — p=0.4742
Summary
This study involves research. Pregabalin is a Food and Drug Administration (FDA) medication approved in the United States for the treatment of nerve pain related to diabetes and post-herpetic neuralgia "shingles", and for seizures in adults. The purpose of this research is to study the effect of oral Pregabalin on spinal neurotransmitters in subjects undergoing Total Knee Replacement Surgery (TKA). TKA is associated with considerable postoperative pain which if unrelieved may result in prolonged hospital stay, inability to participate in rehabilitation programs, poor outcomes, and greater use of health-care resources. This study examines the effect of pregabalin administered for TKA on pain-related neurotransmitter concentrations.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY NRS Pain Score AUC (NRS*hr) - 1st 24 Hours |
70.4; 59.6; 73.4 | 0.4742 |
| PRIMARY NRS Pain Score AUC (NRS*hr) - 1st 12 Hours |
30.1; 22.7; 27.7 | 0.4321 |
| SECONDARY Active Knee Flexion |
78.1; 80.5; 80.5 | 0.7596 |
| SECONDARY Passive Knee Flexion |
86.5; 88.2; 87.1 | 0.9361 |
Eligibility Criteria
Inclusion Criteria
- History of osteoarthritis
- Subjects who can understand and communicate in English
Exclusion Criteria
- Younger than 55 years or older than 75 years.
- American Society of Anesthesiologists physical status IV
- Prior use of pregabalin or gabapentin will not be an exclusionary criterion; however patients will have been withdrawn from these medications at least 14 days before surgery
- Patients who are currently enrolled in another investigational study.
Data sourced from ClinicalTrials.gov (NCT00729690). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.